{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2017-00848", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20171215", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20171129", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20171215", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "900178", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171215", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS4000 A70P6B", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20171215", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20171129", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "7121939", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20171129", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "95005623", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "67 - AT THIS TIME, THE ROOT CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. AT ONE POINT DURING THE SURGICAL PROCEDURE, THE CSR NOTICED THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY HAD COME LOOSE AND WAS APPROXIMATELY 2 MM FROM COVERING THE ORANGE SURFACE ON THE DISTAL END OF THE MCS INSTRUMENT. THE MCS TIP COVER ACCESSORY IS PROPERLY INSTALLED WHEN THE ORANGE SURFACE IS COMPLETELY COVERED ON THE DISTAL END OF THE MCS INSTRUMENT. THE INSTRUMENT & ACCESSORIES USER MANUAL STATES: WARNING: FAILURE TO INSTALL THE TIP COVER ACCESSORY PROPERLY MAY RESULT IN: O IMPROPER SCISSOR OPENING O TIP COVER ACCESSORY FALLING OFF O ELECTRICAL ARCS AND ALTERNATE SITE BURNS THE CSR ADVISED THE SURGICAL STAFF TO REMOVE THE MCS INSTRUMENT AND PULL UP THE MCS TIP COVER ACCESSORY TO COVER THE ORANGE SURFACE. AT ANOTHER POINT, DURING THE SURGICAL PROCEDURE, THE MCS TIP COVER ACCESSORY FELL OFF THE MCS INSTRUMENT. HOWEVER, THE SURGICAL STAFF WAS ABLE TO RETRIEVE THE INSTRUMENT ACCESSORY DURING THE SAME SURGICAL PROCEDURE. THE SURGEON BELIEVED THE MCS TIP COVER ACCESSORY CAME OFF AS A RESULT OF THE USE OF LUBRICATION. THE SURGEON INDICATED THAT THE MCS INSTRUMENT WAS NEVER FIRED WITH THE MCS TIP COVER ACCESSORY NOT INSTALLED. THERE IS NO ALLEGATION THAT THE MCS TIP COVER ACCESSORY COMING LOOSE OR FALLING OFF CONTRIBUTED TO THE REPORTED BOWEL INJURIES. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2017. BASED ON THE AVAILABLE SYSTEM LOGS, NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, SYSTEM LOGS REVEAL THAT THE MCS INSTRUMENT INVOLVED WITH THE REPORTED EVENT HAS BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES. AS OF THE DATE OF THIS REPORT, NO COMPLAINTS INVOLVING THE MCS INSTRUMENT HAVE BEEN REPORTED TO ISI. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE 3 UNSPECIFIED BOWEL INJURIES THAT REQUIRED REPAIR VIA OPEN SURGERY. HOWEVER, THE ROOT CAUSES OF THE BOWEL INJURIES ARE UNKNOWN." }, { "mdr_text_key": "95005624", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT TWO DAYS AFTER UNDERGOING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION, THE PATIENT WAS FOUND TO HAVE THREE UNSPECIFIED BOWEL INJURIES THAT WERE INITIALLY SUSPECTED TO BE DUE SOLELY DUE TO THE LARGE AMOUNT OF ADHESIONS INVOLVING THE BOWEL. DUE TO THE BOWEL INJURIES, THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE. ON 12/07/2017, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE OPERATIVE COMPLICATIONS: THE SURGEON INDICATED THAT IS IT IMPOSSIBLE TO KNOW WITH CERTAINTY WHAT CAUSED THE BOWEL INJURIES. THE SURGEON EXPLAINED THAT THE PATIENT HAD SEVERAL PREVIOUS ABDOMINAL SURGERIES AND THERE WERE SO MANY ADHESIONS. THE SURGEON REPORTEDLY ADMITTED THAT HE ACCIDENTALLY PERFORATED THE PATIENT'S BOWEL IN THIS CASE WHICH REQUIRED REPAIR. THE SURGEON ALSO INDICATED THAT ANOTHER GYN SURGEON WAS CALLED INTO THE CASE TO FREE UP A RETAINED OVARY. ACCORDING TO THE CSR, THERE IS REALLY NO TELLING WHERE THE INJURIES CAME FROM. ON 12/13/2017, ISI CONTACTED THE CSR. THE CSR STATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE AND THE PATIENT HAD TREMENDOUS ADHESIONS. DURING THE FEW MINUTES OF THE CASE, THE SURGEON PERFORMED BLUNT DISSECTION OF THE LEFT LATERAL SIDEWALL. AFTER PEELING AWAY ADHESIONS, THE SURGEON NOTICED A HOLE ON THE PATIENT'S BOWEL. THE SURGEON SEWED UP THE BOWEL INJURY WHICH HE ATTRIBUTED TO THE DENSE ADHESIONS. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI INSTRUMENT OCCURRED OR CAUSED/CONTRIBUTED TO THE BOWEL INJURY. AFTER THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS NOT DOING WELL AND WAS BROUGHT BACK TO THE OR ON POST-OPERATIVE DAY 2. WHILE UNDERGOING OPEN SURGERY, THREE ADDITIONAL BOWEL INJURIES WERE IDENTIFIED AND REPAIRED. AT THIS TIME, THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS DOING WELL ACCORDING TO THE CSR. THE PRIMARY CONSOLE SURGEON AND GYN SURGEON WHO ASSISTED DURING THE CASE DO NOT KNOW THE CAUSES OF THE THREE BOWEL INJURIES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }